摘要
目的 建立HPLC法测定盐酸度洛西汀片的含量.方法 色谱柱为Inertsil CN-3(4.6 mrn×250 mrn,5μm),流动相为0.05 mol/L磷酸二氢钾溶液(用三乙胺调节pH为6.0)-乙腈(30:70),流速为1.0mL/min,检测波长为228 nm.结果 盐酸度洛西汀的线性范围为8.0~71.9 mg/L,r =0.999 9;平均回收率为100.0%,RSD =0.31%.结论 本方法方便、快速、准确,可用于该制剂的质量控制.
Objective To establish an HPLC method for determining the content in duloxetine hydrochloride tablets.Methods A inertsil CN-3 (4.6 mm × 250 mm,5 μm) column was used with 0.05 mol/L potassium dihyduogen phosphate solution (adjusted to pH 6.0 with tdethanolamine)and acetonitdle (30:70)as the mobile phase,the flow rate was 1.0 mL/min,the detective wavelength was 228 nm.Results The linear range was 8 ~ 72 mg/L,r =0.999 9,the average recovery rate was 100.0% and the RSD was 0.31%.Conclusion The method is convenient,sensitive and accurate.It can be used for the quality control of duloxetine hydrochloride tablets.
出处
《实用药物与临床》
CAS
2013年第8期716-717,共2页
Practical Pharmacy and Clinical Remedies
关键词
HPLC
盐酸度洛西汀片
含量
HPLC
Duloxetine Hydrochloride tablets
Content